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A Extension Study of Udenafil in Adolescents
NCT03013751 · View on ClinicalTrials.gov ↗
Study Summary
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
Conditions Studied
Interventions
- DRUG Udenafil
Study Locations (20)
California
- Cedars/Sinai Heart Institute — Los Angeles
- Rady Children's Hospital — San Diego
Missouri
- Children's Mercy Hospital Kansas City — Kansas City
- Washington University St. Louis/St.Louis Children's Hospital — St Louis
Arizona
- Phoenix Children's Hospital/Children's Heart Center at Phoenix Children's Hospital — Phoenix
Colorado
- Children's Hospital Colorado — Aurora
Delaware
- Nemours Cardiac Center/Alfred I. duPont Hospital for Children — Wilmington
District of Columbia
- Children's National Medical Center — Washington D.C.
Florida
- Johns Hopkins All Children's Heart Institute — St. Petersburg
Georgia
- Children's Healthcare of Atlanta — Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2017-02-06 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03013751
The ClinicalTrials.gov registry entry for NCT03013751 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mezzion Pharma Co., which has 30 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Functional Single Ventricle Heart Disease appearing as the primary indexed condition, and to 1 intervention — of which Udenafil is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03013751 reports 20 study locations spanning 18 distinct geographic areas — top geographies include California, Missouri, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03013751 about?
NCT03013751 is a clinical study titled "A Extension Study of Udenafil in Adolescents". This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart disease.
What is the current status of trial NCT03013751?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2017-02-06. Estimated completion is 2022-12-20.
What conditions does trial NCT03013751 study?
This clinical trial studies the following conditions: Functional Single Ventricle Heart Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03013751?
The interventions under investigation include: Udenafil (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03013751?
This trial is sponsored by Mezzion Pharma Co., which has 30 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03013751 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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